Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06699992
Eligibility Criteria:
Inclusion Criteria:
* consecutive subjects with a clinical indication to undergo lumbar puncture for the determination of cerebrospinal fluid biomarkers of amyloidosis, tauopathy, and neurodegeneration during diagnostic assessments for cognitive impairment (as per clinical practice)
* informed consent form signed by patient or caregiver
Exclusion Criteria:
* Age under 50 or over 80 years
* Non-native Italian speakers
* History of previous or concurrent neurological diseases that could impact cognition (e.g., severe cerebrovascular accidents, brain tumors, traumatic injuries, etc.)
* History of major psychiatric disorders that could affect cognitive abilities
* History of alcohol use disorder
* Medical conditions that may interfere with cognitive functions (e.g., renal or hepatic failure, respiratory diseases, hypothyroidism, vitamin B12 deficiency, etc.)
* Uncompensated systemic disease with instability and significant organ failure
* Contraindications to lumbar puncture (e.g., presence of spinal malformations or current use of anticoagulant therapy)
* Previous or current participation in experimental studies involving amyloid-targeting agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06699992
Study Brief:
Protocol Section:
NCT06699992